A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol

BACKGROUND: Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, ie, abnormal accumulation of lymph fluid in the ipsilateral upper limb or body. Grounded in research-driven behavioral strategies, The-Optimal-Lymph-Flow is a unique Web- and mobile-based system focusing on self-care strategies to empower, rather than inhibit, how breast cancer survivors manage daily pain and symptoms. It features a set of safe, feasible, and easily-integrated-into-daily-routine exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal body mass index (BMI). OBJECTIVE: To conduct a randomized clinical trial (RCT) to evaluate the efficacy of the Web- and mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference by infra-red perometer, BMI, and quality of life (QOL) related to pain. We hypothesize that participants in the intervention group will have improved pain and symptom experiences, limb volume difference, body mass index, and QOL. METHODS: A parallel RCT with a control-experimental, pre- and post-test, repeated-measures design is used in this study. A total of 120 patients will be randomized according to the occurrence of pain. Participants will be recruited face-to-face at the point of care during clinical visits. Participants in the intervention group will receive the Web- and mobile-based The-Optimal-Lymph-Flow intervention and will have access to and learn about the program during the first in-person research visit. Participants in the control group will receive the Web- and mobile-based Arm Precaution program and will have access to and learn about the program during the first in-person research visit. Participants will be encouraged to enhance their learning by accessing the program and following the daily exercises during the study period. Participants will have monthly online self-report of pain and symptoms at 4 and 8 weeks post-intervention. During the two in-person research visits prior to and 12 weeks post-intervention, participants will be measured for limb volume difference, BMI, and complete self-report of pain, symptoms, self-care behaviors, and QOL. RESULTS: This trial is currently open for recruitment. The anticipated completion date for the study is July 2017. The primary endpoint for the study is absence or reduction of pain reported by the participants at week 12 post-intervention. CONCLUSIONS: The-Optimal-Lymph-Flow is a unique Web- and mobile-based self-care and patient-reported outcome system designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Patients learn self-care strategies from a Web- and mobile-based program and track their symptoms. The RCT will directly benefit all women treated for breast cancer who suffer from or at risk for pain and symptoms related to lymph fluid accumulation. TRIAL REGISTRATION: Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 (Archived by WebCite at http://www.webcitation.org/6du4IupG5)